Quality Engineering Associate III - CQV

Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.

We are seeking a Quality Engineer III to lead equipment and facilities CQV (Commissioning, Qualification, and Validation) activities and drive continuous improvement initiatives for Capricor’s GMP facility in San Diego. This senior-level role ensures compliance with internal procedures and regulatory guidelines while providing technical leadership in risk management, vendor qualification, and audit readiness. You will serve as a key resource for greenfield and brownfield facility projects, guiding quality engineering strategies that support operational excellence and regulatory compliance.

• Lead CQV activities for equipment and facilities in alignment with Capricor procedures and regulatory standards.
• Author and approve validation protocols, reports, and related documentation.
• Collaborate with Manufacturing, Facilities, Safety, and Quality teams to maintain compliance and operational efficiency.
• Drive process improvements and implement best practices across quality systems.
• Review calibration, preventive maintenance, and service reports for GMP equipment and facilities.
• Provide technical assessments and evaluations within the change control process.
• Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees.
• Oversee vendor qualification and compliance audits; prepare technical and investigation reports as needed.
• Support internal and external audits, including regulatory inspections.
• Track and report key quality metrics to inform continuous improvement initiatives.
• Lead quality-related projects and mentor junior team members.
• Perform additional duties as required.

• Bachelor’s degree in a scientific or engineering discipline and 3+ years of experience in a pharmaceutical or FDA-regulated environment.
• Minimum of 3 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product).
• Strong knowledge of CQV principles and quality systems.
• Experience leading greenfield or brownfield facility buildouts preferred.
• Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10).
• Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt.
• Proficiency in Microsoft Word, Excel, PowerPoint, and related applications.
• Excellent written and verbal communication skills.
• Ability to work independently and collaborate effectively with technical teams.

• Professional GMP facility environment.
• Ability to sit or stand for extended periods.
• Occasional lifting of materials up to 40 pounds.

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.